PMA P820076S011
- Device
- GEMNOS (TM) CARDIAC PACEMAKER (4.34)
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S011
- Product code
- LWP
- Decision date
- 1991-12-20
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- GEMNOS (TM) CARDIAC PACEMAKER (4.34)
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S011
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1991-12-20
- Decision code
- APPR
- Date received
- 1991-01-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material